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Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT01689597
Recruitment Status : Withdrawn (Withdrawn - no participants enrolled)
First Posted : September 21, 2012
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.

Condition or disease Intervention/treatment Phase
Traumatic Vaginal Delivery Drug: Morphine Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study
Anticipated Study Start Date : September 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Low dose epidural morphine
One dose of 1.25 mg epidural morphine
Drug: Morphine
Comparison of different dosages of drug
Active Comparator: High dose epidural morphine
One dose of 2.5 mg epidural morphine
Drug: Morphine
Comparison of different dosages of drug
Placebo Comparator: Saline
One dose of 10 ml saline administered through an epidural catheter
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Total breakthrough opioid consumption [ Time Frame: First 24 hours after delivery ]

Secondary Outcome Measures :
  1. Pain scores at rest [ Time Frame: At 6, 12, 24, and 36 h after delivery ]
  2. Pain scores with movement [ Time Frame: At 6, 12, 24, and 36 h after delivery ]
  3. Severity of nausea/vomiting [ Time Frame: At 6, 12, 24, and 36 h after delivery ]
  4. Severity of pruritis [ Time Frame: At 6, 12, 24, and 36 h after delivery ]
  5. Severity of sedation [ Time Frame: At 6, 12, 24, and 36 h after delivery ]
  6. Time to first request for additional analgesia [ Time Frame: First 36 h after delivery ]
  7. Patient satisfaction with pain control [ Time Frame: At 24 and 36 h after delivery ]
  8. Quality of Recovery [ Time Frame: At 24 and 36 h after delivery ]
  9. Antiemetic consumption [ Time Frame: First 36 h after delivery ]
  10. Antipruritic medication consumption [ Time Frame: First 36 h after delivery ]
  11. Total opioid consumption [ Time Frame: First 36 h after delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is 18 years or older
  • The patient is ASA 1-3
  • Gestation 37-42 weeks
  • The patient had a vaginal delivery
  • The patient received epidural analgesia for labor and delivery

Exclusion Criteria:

  • The patient has refused to participate
  • The patient cannot give informed consent
  • The investigator has significant concerns for maternal or neonatal welfare
  • The patient has a history of allergy to opioids
  • The patient has a history of chronic opioid consumption
  • The patient has a history of narcotic abuse
  • The patient has an allergy to local anesthetics
  • The patient has a contraindication to taking NSAIDs or acetaminophen
  • The patient received combined spinal-epidural analgesia
  • The patient has a history of chronic pain
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689597


Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Sudha I Singh, MD FRCPC University of Western Ontario, Canada
More Information

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01689597     History of Changes
Other Study ID Numbers: 18501
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2012

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents